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Behavioral Intervention for Chronic Pain and Depression in Older Veterans (MOTIVATE_IIR Trial)

N/A

Recruiting

Led By Una E. Makris, MD MSc

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain intensity that is 4+/10 on the numerical pain rating scale

Aged 60 and older

Must not have

Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA* (resulting in inability to participate in physical activity intervention)

Unwilling to be randomized to either study arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid (~5 weeks), end (~3 months) and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new pain management program for older Veterans with both chronic pain and depression.

Who is the study for?

This trial is for older Veterans aged 60+ who speak English, have chronic musculoskeletal pain and depressive symptoms. They must be able to do home-based activities, score 10+ on the PHQ-9 depression scale, experience pain most days with an intensity of 4+/10 and interference level of 5+ on PEG-3. Exclusions include severe cognitive impairment, recent hospitalization that affects physical activity, suicidal intent or uncontrolled psychotic disorders.

What is being tested?

The MOTIVATE program is being tested in this study. It's a behavioral intervention aimed at improving outcomes for older veterans dealing with both musculoskeletal pain and depression by using non-pharmacologic methods tailored to be done at home.

What are the potential side effects?

Since MOTIVATE is a behavioral intervention involving non-drug approaches like exercise and mental health strategies rather than medication, it may not have typical 'side effects.' Participants might experience discomfort from new activities or emotional distress during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is at least 4 out of 10.

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I am 60 years old or older.

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I have scored 10 or higher on a depression screening test.

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I have had muscle or joint pain almost daily for the past 3 months that affects my daily activities.

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My pain often interferes with my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on a wheelchair, am bed-bound, or have severe balance issues or osteoarthritis that prevents me from being active.

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I am not willing to be assigned randomly to a treatment group.

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I can hear and see well enough to use a phone and read a pedometer.

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I do not speak English.

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I haven't been hospitalized for a condition that would stop me from exercising at home in the last 3 months.

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I am 59 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid (~5 weeks), end (~3 months) and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid (~5 weeks), end (~3 months) and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid (~5 weeks), end (~3 months) and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

: Pain interference

Secondary study objectives

Anxiety

Arthritis self-efficacy

Depressive symptoms, PHQ-9

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavior Intervention Group (MOTIVATE)Experimental Treatment1 Intervention

For participants assigned to the intervention arm, trained health coaches will deliver the 8 session intervention via telephone. MOTIVATE users motivational interviewing techniques, values elicitation and physical activity based goal setting. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant.

Group II: Waitlist Control GroupActive Control1 Intervention

The waitlist control group will continue with usual care management of musculoskeletal pain and depression. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the intervention once they have completed the end outcomes assessment.

0 / 11Eligibility criteria met